Low-dose oral ferrous sulphate versus ferrous fumarate for treatment of iron deficiency anaemia: An open label randomized controlled trial

JIPMER, Puducherry1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2026年2月23日最近更新: 2026年2月7日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方: JIPMER, Puducherry
入组人数: 100
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, open label, parallel group, single centre trial comparing the safety and efficacy of Ferrous sulphate 200 mg daily and Ferrous fumarate 200 mg daily for 3 months in 100 patients with iron deficiency anemia . The primary outcome is the haemoglobin increment at 4 weeks (from baseline) in the two arms. The secondary outcomes will be adverse effects related to treatment, treatment compliance and hemoglobin increments at weeks-2,8 and 12 in the two arms.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Newly diagnosed patients with iron deficiency anemia of either sex Iron deficiency anemia is defined as Hemoglobin concentration between 6-10g/dl, serum ferritin concentration of less than 30 microgram/L and peripheral blood picture consistent with iron deficiency anemia.

排除标准

•Patients with iron deficiency anemia with cardiac failure Pregnant and lactating women Patient who has already been diagnosed to have iron deficiency anemia and receiving oral iron therapy Patients requiring urgent blood transfusion for anemia Patients with known allergy to ferrous sulphate or ferrous fumarate Patients known to have thalassemia Patients known to have malabsorption syndrome Patients known to have peptic ulcer disease Patients known to have coronary artery disease Patients known to have chronic kidney disease with serum creatinine of more than 2mg/dL Patients known to have liver disease Alcohol abuse with Alcohol intake of more than once per week Overt Gastrointestinal bleeding Patient who received acid suppressive therapy for more than 1 month Dimorphic or Megaloblastic picture on peripheral smear examination Patients known to have Anemia of chronic disease secondary to systemic lupus erethematousus, inflammatory bowel disease, HIV, Tuberculosis.

研究者

发起方

JIPMER, Puducherry

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Vinod K V

JIPMER

研究点 (1)

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